(332 days)
The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, and ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The SurFuse™ and ExFuse™ family of products are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty or gel-like consistency. The ExFuse™ products also contain cancellous bone powder. The products are provided sterile for single patient use.
The provided text is a 510(k) summary for the HansBiomed Corp. SurFuse™ and ExFuse™ devices. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically seen for AI/ML-driven software as a medical device.
Therefore, the requested information specifically related to acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and ground truth types are not available in the provided document, as these are primarily associated with the validation of AI/ML diagnostic or prognostic algorithms.
The document discusses safety and performance in a more general sense for a bone void filler product, focusing on biocompatibility, osteoinductivity, and osteoconductivity, rather than an AI/ML algorithm's analytical or clinical performance.
Here's a breakdown of what can be extracted and what is missing:
The device is a physical medical device (resorbable bone void filler), not an AI/ML software. Therefore, the parameters typically used to describe AI/ML studies are not relevant or present.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for quantitative metrics in an AI context. Instead, the acceptance is based on demonstrating safety (biocompatibility, viral inactivation) and performance (osteoinductivity, osteoconductivity) through established biological and in vivo models.
- Reported Device Performance:
- Safety:
- Donor bone obtained from AATB-certified tissue banks, screened for infectious viruses.
- Manufacturing and sterilization processes validated to inactivate HIV-1, Bovine Herpes Virus (BHV), Bovine Viral Diarrhea Virus (BVDV), Hepatitis A Virus (HAV), and Porcine Parvovirus (PPV).
- Biocompatibility testing (according to ISO 10993) performed, demonstrating devices are safe, nontoxic, and biocompatible.
- Performance:
- Osteoconductive ability: Successfully grown bone in the in vivo rabbit spinal model.
- Osteoinductive potential:
- Demonstrated new bone growth within muscle tissue in the athymic (nude) rat muscle pouch model.
- Evaluated with a surrogate, in vitro BMP-2 ELISA assay, with results correlated with successful bone formation in the athymic rat for the same lots.
- Each lot will be evaluated for osteoinductive potential using the in vitro assay.
- Safety:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified for human data. For preclinical studies:
- Rabbit spinal model: Sample size not specified.
- Athymic (nude) rat muscle pouch model: Sample size not specified.
- Data Provenance: Preclinical animal models (rabbit and rat). Human data (if any for testing) is not described. Donor bone is sourced from AATB-certified tissue banks in the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for this type of device relies on biological outcomes in animal models (e.g., bone formation observed histologically) and in vitro assays, not on expert human interpretation of medical images or clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human expert interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth (for performance):
- Observation of bone formation in vivo (rabbit spinal model, athymic rat muscle pouch model).
- Results of in vitro BMP-2 ELISA assay correlated with in vivo bone formation.
- Ground Truth (for safety/biocompatibility):
- Viral inactivation validation studies.
- ISO 10993 biocompatibility testing results.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this physical device.
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Submitter:
Hans Biomed Corp.
SurFuse™ and ExFuse™
Traditional 510(k)
510(k) SUMMARY
| Submitter Name: | HansBiomed Corp. |
|---|---|
| Submitter Address: | 8 Floor SK Building Seongsu 1-gaSeongdong-guSeoul, 133-110 Korea |
| Contact Person: | Ms. Lucy Choi |
| Phone Number: | 0082 2 466 2266 |
| Fax Number: | 0082 2 463 1554 |
| NOV 15 2012 | |
| Date Prepared: | December 19, 2011 |
| Device TradeName: | SurFuse™ Gel, SurFuse™ Putty,ExFuse™ Gel, ExFuse™ Putty |
| Device CommonName: | Resorbable bone void filler, human bone graft material |
| ClassificationNumber: | 21 CFR 888.3045 |
| Product Code and | MQV and MBP |
| Classification Name | Filler, bone void, calcium compoundFiller, bone void, Osteoinduction (w/o Human Growth Factor) |
| Device Class | II |
| Predicate Devices: | K040419, DynaGraft II Gel and Putty, IsoTis OrthoBiologics, Inc.K053319, Allomatrix® Cusotm Putty, Wright MedicalTechnology, Inc. |
| Statement ofIntended Use: | The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, andExFuse™ Putty products are indicated for bony voids or gapsthat are not intrinsic to the stability of the bony structure. Theyare intended to be gently packed into bony voids or gaps of theskeletal system (posterolateral spine). These defects may besurgically created osseous defects or osseous defects createdfrom traumatic injury to the bone. |
| Device Description: | The SurFuse™ and ExFuse™ family of products are derivedfrom human allograft bone tissue that is processed into apowder and demineralized using a hydrochloric acid process.The demineralized bone matrix (DBM) is combined with aresorbable carrier, carboxymethylcellulose (CMC) andformulated into a putty or gel-like consistency. The ExFuse™products also contain cancellous bone powder. The productsare provided sterile for single patient use. |
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SurFuse™ and ExFuse™ Traditional 510(k)
Safety:
The donor bone is obtained from AATB-certified tissue banks in the United States. The tissues are screened for the standard panel of infectious viruses. Further the manufacturing and sterilization processes have been validated to inactivate the HIV-1, Bovine Herpes Virus (BHV), Bovine Viral Diarrhea Virus (BVDV), Hepatitis A Virus (HAV) and Porcine Parvovirus (PPV).
Biocompatibility testing, according to ISO 10993, has been performed and the devices have been shown to be safe, nontoxic and biocompatible.
Performance:
The devices were tested successfully to fully characterize their osteoconductive ability to grow bone in the in vivo rabbit spinal model.
They also have been tested in vivo in the athymic (nude) rat muscle pouch model and were shown to have osteoinductive potential, in that new bone grew within the muscle tissue. The osteoinductive potential also was evaluated with a surrogate, in vitro BMP-2 ELISA, assay. Results from that assay were correlated with results from the same lots in which bone successfully formed in the athymic rat.
Each lot of the SurFuse™ and ExFuse™ devices will be evaluated for osteoinductive potential using the in vitro assay.
Osteoinduction assay results observed in surrogate assessments should not be interpreted to predict clinical performance in human subjects.
Comparison to the Predicate Devices:
These device families, with respect to material composition, device characteristics and intended use, are substantially equivalent to the two predicate device families.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 15, 2012
Hans Biomed Corporation % Trisler Consulting Ms. Patsy J. Trisler, JD, RAC Regulatory Consultant 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815
Re: K113728
Trade/Device Name: SurFuse" Gel and Putty, ExFuse™ Gel and Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV, MBP Dated: October 22, 2012 Received: October 25, 2012
Dear Ms. Trisler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 -- Ms. Patsy J. Trisler, JD, RAC
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Laurence D. Coyne
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SurFuse™ and ExFuse™ Traditional 510(k)
510(k) Number (if known):
Device Name:
SurFuse™ Gel and Putty ExFuse™ Gel and Putty
Indications for Use:
The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, and ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony . structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Samuel V. Gammon
(Division Sign-Off) Division of Orthopedic Devices 310(k) Number K113728
Section 4.0
Page 1 of 1
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.